Recall Z-0357-2012 ยท FCW Light Source, Fiberoptic, Routine
Integra LifeSciences Corp.
Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.
| Date | Dec 2, 2011 (initiated Oct 14, 2011) |
| Status | Terminated |
| Reason | A loose screw may result in shifting of components and improper function of the turret or actuator assembly. |
| Root cause | Process control |
| Action | Integra sent an URGENT: Field Corrective Action letter dated October 14, 2011 to all affected customers via FedEx. The letter identified the affected product, the problem, and the actions to be taken with instructions to immediately inspect their inventory for potentially loose screws within the affected unit(s). If the unit(s) were observed with loose screws, the unit(s) were to be returned to Integra Surgical for repair and servicing. Customers were instructed to complete the Acknowledgement and Return Form per the instructions on the form. For questions call Integra Surgical Customer Se |
| Quantity | 12 |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of: Arizona, California, Colorado, Florida, Indiana, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Montana, Washington, Wyoming, and Puerto Rico, and the countries of: Australia, Germany, Italy, Japan, Nether |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081477 | LUXTEC MLX LIGHT SOURCE Integra Luxtec, Inc., Jun 18, 2008 |